FDA warns GSK’s HIV drug may increase risk of heart attack

ROCKVILLE, Md. The Food and Drug Administration and GlaxoSmithKline have warned healthcare professionals of the risk of heart attack and buildup of cholesterol in patients taking a drug used to treat HIV.

The FDA released an alert Thursday announcing that it had modified the prescription information for the drug Lexiva (fosamprenavir calcium) to note that some patients taking the drug have experienced increases in cholesterol, a condition known as dyslipidemia, and recommend that patients undergo cholesterol and triglyceride testing before and during therapy with the drug.

In other news, the agency warned of possible birth defects among babies born to women who take the epilepsy drug valproate sodium and related drugs during pregnancy, including defects of the head and face and circulatory systems. Valproate sodium and related drugs are mostly available as generics, and Abbott Labs markets them under brand names such as Depacon (valproate sodium injection) and Depakote (divalproex sodium tablets).

Sandoz introduces hypertension generic

PRINCETON, N.J. The generics arm of Swiss drug maker Novartis has introduced a version of a hypertension drug.

Sandoz announced the introduction of the injected drug nicardipine, a generic version of EKR Therapeutics’ Cardene, in 2.5 mg vials. The drug is designed for the short-term management of hypertension when treatment with orally administered drugs is not feasible.

Cardene had sales of $200 million during the 12-month period ended in September, according to IMS Health.

Study finds life expectancy for young adults diminished by obesity

NEW YORK Though the number of Americans who smoke has decreased dramatically in recent years, increases in obesity threaten to erase potential gains in the average life expectancy of young adults, according to a new study.

A team of researchers, led by Susan Stewart of the nonprofit National Bureau of Economic Research, published the study Thursday in The New England Journal of Medicine, forecasting the life expectancy of the average 18-year-old between 2005 and 2020 by comparing data on smoking and obesity.

The researchers used National Health Interview Survey data on smoking from two-year intervals between 1978 and 2006, as well as past trends in body-mass index based on data from the National Health and Nutrition Examination Survey in four- to six-year intervals between 1971 and 2006. They also factored in the 2003 Medical Expenditure Panel Survey to examine the effects of smoking and body-mass index on health-related quality of life.

While declining rates of smoking would increase the average life expectancy of 18-year-olds, increasing rates of obesity would push it back down by eight to 11 months, the researchers found. By contrast, if all adults in the United States became nonsmokers of normal weight, life expectancies would increase by up to five years.

“If past obesity trends continue unchecked, the negative effects on the health of the U.S. population will increasingly outweigh the positive effects gained from declining smoking rates,” the authors wrote. “Failure to address continued increases in obesity could result in an erosion of the pattern of steady gains in health observed since early in the 20th century.”

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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